FDA recall, , Moderate risk
Terumo Glidesheath Slender A-Kit
The Glidesheath Slender was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
Summary by Recall Canary from the FDA notice
What happened
Terumo Medical Corporation of Elkton, Maryland, recalled the Glidesheath Slender a-Kit 6F 10CM .021GW, 5 units per box, product code 60-1060, because the product was packaged with the 0.025 guidewire instead of the 0.021 guidewire. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery. The recall began June 15, 2026, and was added to the FDA's Enforcement Report on August 10, 2026, with distribution nationwide and in Canada.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Glidesheath Slender a-Kit 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The
- UDI-DI
- 30389701011975
- 00389701011974
- 0001441871
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the country of Canada.
- Company
- Terumo Medical CorporationElkton, Maryland
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99285
- Recall number
- Z-2930-2026
- Quantity recalled
- 7,490 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
